Tipifarnib in Treating Patients With Anemia or Neutropenia and Large Granular Lymphocyte Leukemia (NCT00360776) | Clinical Trial Compass
TerminatedPhase 2
Tipifarnib in Treating Patients With Anemia or Neutropenia and Large Granular Lymphocyte Leukemia
United States25 participantsStarted 2006-06-02
Plain-language summary
This phase II trial is studying how well tipifarnib works in treating patients with anemia or neutropenia and large granular lymphocyte leukemia. Tipifarnib may stop the growth of leukemia by blocking blood flow to the cancer cells and by blocking some of the enzymes needed for cancer cell growth.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of T-cell-large granular lymphocyte (LGL) leukemia or natural killer (NK)-LGL leukemia associated with ≥ 1 of the following clinical manifestations:
* Severe neutropenia (i.e., \< 500/mm³)
* Neutropenia associated with recurrent infections, meeting 1 of the following criteria: one severe infection requiring hospitalization or at least 2 infections requiring antibiotic therapy
* Symptomatic anemia with significant fatigue with a score of greater than 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale; dyspnea on exertion, but able to walk one flight of stairs without stopping (less than grade 1 respiratory symptoms); cardiac symptoms including worsening of angina or new onset of chest pain
* Transfusion-dependent anemia
* Willing to discontinue use of MTX, Cy, or cyclosporine for 1 month prior to study entry
* T-cell-LGL leukemia must meet all of the following criteria: CD3+ and CD57+ cells \> 300/mm³ or CD8+ cells \> 650/mm³ by phenotypic studies of peripheral blood, evidence for clonal T-cell receptor gene rearrangement based on positive flow cytometric analysis, T-cell receptor (TCR)-γ chain polymerase chain reaction (PCR), TCR-Vβ PCR, or by Southern blot analysis
* NK-LGL leukemia must have CD56+ or CD16+ NK cells \> 750/mm³ by phenotypic studies of peripheral blood
* Life expectancy \> 2 years
* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Fertile patients must use effective contraception pri…
What they're measuring
1
Response rates to tipifarib defined as the proportion of patients achieving a complete response (CCR) or partial response (PR)